STD Med, Inc. has an opening for an Engineering Compliance Officer. Responsibilities include but are not limited to:

Candidate should hold a Master’s degree in Engineering or related field. Three to seven years relevant work experience or equivalent combination of education and experience. Must have a solid working knowledge of the FDA QSR, ISO 9000, EN 13485 and International Medical Device Directives.

• Drafts, edits, compiles, and obtains internal approval of routine correspondence regarding regulatory filings and related supplements and amendments.
• Works in partnership with Engineering, manufacturing and QA/QC in designing and enhancing quality management systems to facilitate overall regulatory compliance.
• Maintains internal and external compliance with audit programs, and manages site inspections by Federal and international regulatory agencies.
• Acts as regulatory liaison for medical or clinical research groups to keep regulatory affairs department apprised of research progress.
• Plans and conducts the analysis, inspection, design, test, and/or integration to assure the Quality of assigned Material, Component and Product.
• Performs Quality Engineering reviews of design documentation for compliance with stated requirements, including Supplier Quality Manuals and company Quality Records.
• Documents data obtained during all Quality Assurance activities, consistent with company policies and procedures.
• Communicates significant issues and Standards identified during Quality Assurance, Engineering and Regulatory activities and provides recommended process improvements to management.
• Develop Procedures and prepares Reports to support the Quality and Regulatory System and communicate involvement and results of Quality Assurance activities.
• Prepares and presents technical and program information to team members and management
• Directs technical and administrative workers engaged in Quality Assurance and Regulatory activities.
• Maintains a working knowledge of government and industry Quality Assurance codes and standards.